Importation of Ovine Meat From Uruguay, 10266-10269 [2011-4138]
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10266
Proposed Rules
Federal Register
Vol. 76, No. 37
Thursday, February 24, 2011
Animal and Plant Health
Inspection Service, USDA.
ACTION: Proposed rule.
Reading Room: You may read any
comments that we receive on this
docket in our reading room. The reading
room is located in room 1141 of the
USDA South Building, 14th Street and
Independence Avenue SW.,
Washington, DC. Normal reading room
hours are 8 a.m. to 4:30 p.m., Monday
through Friday, except holidays. To be
sure someone is there to help you,
please call (202) 690–2817 before
coming.
Other Information: Additional
information about APHIS and its
programs is available on the Internet at
https://www.aphis.usda.gov.
FOR FURTHER INFORMATION CONTACT: Dr.
Silvia Kreindel, Senior Staff
Veterinarian, Regionalization Evaluation
Services Staff, VS, APHIS, 4700 River
Road Unit 38, Riverdale, MD 20737–
1231; (301) 734–8419.
SUPPLEMENTARY INFORMATION:
We are proposing to amend
the regulations governing the
importation of certain animals, meat,
and other animal products to allow,
under certain conditions, the
importation of fresh (chilled or frozen)
ovine meat from Uruguay. Based on the
evidence in a risk assessment that we
have prepared, we believe that fresh
(chilled or frozen) ovine meat can safely
be imported from Uruguay provided
certain conditions are met. These
actions would provide for the
importation of ovine meat from Uruguay
into the United States, while continuing
to protect the United States against the
introduction of foot-and-mouth disease.
DATES: We will consider all comments
that we receive on or before April 25,
2011.
ADDRESSES: You may submit comments
by either of the following methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov/fdmspublic/
component/main?main=DocketDetail&
d=APHIS-2008-0085 to submit or view
comments and to view supporting and
related materials available
electronically.
• Postal Mail/Commercial Delivery:
Please send one copy of your comment
to Docket No. APHIS–2008–0085,
Regulatory Analysis and Development,
PPD, APHIS, Station 3A–03.8, 4700
River Road Unit 118, Riverdale, MD
20737–1238. Please state that your
comment refers to Docket No. APHIS–
2008–0085.
Background
Under the Animal Health Protection
Act (7 U.S.C. 8301 et seq.), the Secretary
of Agriculture may prohibit the
importation of any animal or article if
the Secretary determines that the
prohibition is necessary to prevent the
introduction into or dissemination
within the United States of any pest or
disease of livestock.
Pursuant to this Act, the Animal and
Plant Health Inspection Service (APHIS)
of the United States Department of
Agriculture (USDA) regulates the
importation of animals and animal
products into the United States to guard
against the introduction of animal
diseases not currently present or
prevalent in this country. The
regulations in 9 CFR part 94 (referred to
below as the regulations) prohibit or
restrict the importation of specified
animals and animal products to prevent
the introduction into the United States
of various animal diseases, including
rinderpest and foot-and-mouth disease
(FMD). These are dangerous and
destructive communicable diseases of
ruminants and swine.
Section 94.1 of the regulations lists
regions of the world that are declared
free of rinderpest and FMD. Section
94.11 lists regions that have been
determined to be free of rinderpest and
FMD, but that are subject to certain
restrictions because of their proximity to
or trading relationships with rinderpestor FMD-affected regions.
This section of the FEDERAL REGISTER
contains notices to the public of the proposed
issuance of rules and regulations. The
purpose of these notices is to give interested
persons an opportunity to participate in the
rule making prior to the adoption of the final
rules.
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
9 CFR Part 94
[Docket No. APHIS–2008–0085]
RIN 0579–AD17
Importation of Ovine Meat From
Uruguay
AGENCY:
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SUMMARY:
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In a final rule effective and published
in the Federal Register on May 29, 2003
(68 FR 31940–31949, Docket No. 02–
109–3), we amended the regulations to
authorize the importation of fresh beef
from Uruguay, a region of the world that
we do not recognize as free of FMD,
under certain conditions. Those
conditions, found in § 94.22 of the
regulations, require that the meat come
from bovines that have been born,
raised, and slaughtered in Uruguay, that
the bovines have not been exposed to
FMD on their premises of origin or
through contact with bovines from other
premises, that the bovines are subject to
inspections and processing designed to
detect FMD and remove potentially
affected body parts, that the beef is
subject to a maturation process designed
to deactivate the FMD virus, that
Uruguay is free of FMD for a year prior
to the export of the beef, and that the
beef has not come in contact with meat
from FMD-affected regions.
In 2006, Uruguay’s Ministry of
Livestock, Agriculture, and Fisheries
(MGAP) submitted information to
APHIS in support of their request that
we amend the regulations to allow the
importation of fresh ovine meat into the
United States.
In response to this request, APHIS
prepared a risk assessment, which can
be viewed on the Internet on the
Regulations.gov Web site or in our
reading room.1 This assessment pays
close attention, in particular, to the role
sheep played in the last outbreak of
FMD in Uruguay in 2001, and the
likelihood that FMD has been
introduced into the domestic ovine
population within the country since that
time. In addition, as part of our
evaluation of the risks associated with
Uruguay’s request, APHIS conducted a
site visit in Uruguay in March 2007.
Based on the risk assessment and the
site visit, we have determined that it is
not necessary to prohibit the
importation of fresh (chilled or frozen)
ovine meat from Uruguay, provided
certain requirements, similar to those
described above for fresh beef and
discussed later in this document, are
met. These requirements would be
1 Instructions on accessing Regulations.gov and
information on the location and hours of the
reading room may be found at the beginning of this
document under ADDRESSES. You may also request
paper copies of the risk assessment by calling or
writing the person listed under FOR FURTHER
INFORMATION CONTACT.
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Federal Register / Vol. 76, No. 37 / Thursday, February 24, 2011 / Proposed Rules
nearly identical to the existing
requirements for the importation of beef;
hence we are proposing to revise § 94.22
to authorize the importation of both beef
and ovine meat from Uruguay into the
United States.
Mitigation Measures for the Importation
of Ovine Meat From Uruguay
There are several risk factors
associated with the importation of ovine
meat from Uruguay. We discuss our
proposed mitigation measures for these
risk factors in the following paragraphs.
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Uruguayan Origin of Ovine Meat;
Restrictions on Contact With Meat of a
Different Region of Origin
Currently, paragraph (a) of § 94.22
requires that beef from Uruguay must
come from bovines that have been born,
raised, and slaughtered in Uruguay.
Likewise, paragraph (h) of § 94.22
currently requires that beef from
Uruguay not have been in contact with
meat from regions other than those
listed in § 94.1(a)(2), which lists regions
declared to be free of both rinderpest
and FMD. We would subject ovine meat
from Uruguay to these same
requirements. As documented in our
assessment, Brazil and Argentina,
countries that border Uruguay, both
experienced outbreaks of FMD as
recently as 2006, and FMD is under
control, but endemic, in the region of
South America surrounding Uruguay.
FMD Status of Uruguay
Currently, paragraph (b) of § 94.22
requires that FMD not have been
diagnosed in Uruguay within the
previous 12 months before beef from
Uruguay is exported to the United
States. We would amend the paragraph
so that it would state that, if FMD is
detected anywhere in Uruguay, the
export of beef and ovine meat from all
of Uruguay to the United States is
prohibited until at least 12 months have
elapsed since the depopulation,
cleaning, and disinfection of the last
infected premises. The current
provision could be construed to state
that the 12 month prohibition begins
following diagnosis of the last affected
animal during an outbreak, while
eradication, cleaning, and disinfection
efforts are still ongoing. This is not the
case; it is APHIS’ policy that the 12
month prohibition begins only after all
‘‘stamping out’’ efforts cease.
Premises of Origin
Paragraph (c) of § 94.22 currently
requires that beef from Uruguay
exported to the United States come from
bovines that originated from premises
where FMD has not been present during
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the lifetime of any bovines slaughtered
for the export of beef to the United
States. We would modify paragraph (c)
so that it would pertain to both bovines
and sheep. This measure is necessary
because sheep that have been exposed
to FMD on their premises of origin pose
an unacceptably high risk of spreading
the disease.
Movement From the Premises of Origin
Paragraph (d) of § 94.22 currently
requires that beef from Uruguay come
from bovines that were moved directly
from the premises of origin to the
slaughtering establishment without any
contact with other animals. We would
also subject ovine meat from Uruguay to
this requirement, which addresses the
risk of cattle or sheep coming into
contact with or commingling during
transit to slaughter with animals from
regions in which FMD is known to exist,
or that have not been evaluated by
APHIS with regard to their FMD status.
Ante- and Post-Mortem Inspections
Paragraph (e) of § 94.22 currently
requires that beef from Uruguay come
from bovines that received ante- and
post-mortem veterinary inspections,
paying particular attention to the head
and feet, at the slaughtering
establishment, with no evidence found
of vesicular disease. Because FMD has
a short incubation period, if animals
were infected with FMD at a premises
of origin, it is likely that lesions would
be visible in at least a few of those
animals at the slaughtering
establishment prior to slaughter.
Similarly, post-mortem inspection of
carcasses would be likely to identify any
lesions and vesicles in animals infected
with FMD. Since the lesions associated
with FMD occur primarily on the feet
and in the mouth, particular attention
must be paid to the head and feet during
these inspections. Because ante- and
post-mortem inspections are effective in
reducing disease risk, we are proposing
to also require ante- and post-mortem
inspections for sheep slaughtered for the
export of fresh (chilled or frozen) ovine
meat from Uruguay to the United States.
Restrictions on Certain Ovine Parts
Paragraph (f) of § 94.22 currently
requires that beef from Uruguay consist
only of bovine parts that are, by
standard practice, part of the animal’s
carcass that is placed in a chiller for
maturation after slaughter. Accordingly,
the paragraph prohibits the importation
of all parts of bovine heads, feet, hump,
hooves, or internal organs.
We would apply this requirement to
ovine meat from Uruguay, and would
therefore authorize the importation into
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the United States only of ovine parts
that are, by standard practice, part of the
animal’s carcass that is placed in a
chiller for maturation after slaughter. As
a result, we would continue to prohibit
the importation of ovine heads, feet,
hooves, and internal organs into the
United States; sheep have no humps.
While portions of a sheep’s head, feet,
hooves, and internal organs may reach
the necessary pH level to inactivate the
FMD virus during the required
maturation process (see the section
below titled ‘‘Maturation Process’’),
these items can contain lymph tissue,
depot fat, and blood clots that may
potentially harbor active FMD virus,
even after that process; hence the need
for this requirement.
Bone, Blood Clots, and Lymphoid Tissue
Paragraph (g) of § 94.22 currently
requires all bone and visually
identifiable blood clots and lymphoid
tissue to be removed from beef from
Uruguay prior to export to the United
States. We would subject ovine meat
from Uruguay to this same requirement.
The removal of bones and visually
identifiable blood clots is necessary
because any FMD virus these parts
might potentially harbor may not be
inactivated by the maturation process
described later in this document.
Although we consider the removal of
these parts to be necessary, we
recognize that meat may contain small
portions of blood clots or lymphoid
tissue that are not visually identifiable
as such. Because such small parts are
unlikely to harbor any FMD virus that
is not inactivated by the maturation
process, and because we recognize that
it would be difficult, if not impossible,
to remove parts of blood clots or
lymphoid tissue that are not
recognizable as such, we have specified
that all visually identifiable blood clots
and lymphoid tissue would have to be
removed.
Maturation Process
Paragraph (i) of § 94.22 currently
requires that beef from Uruguay come
from bovine carcasses that were allowed
to maturate at 40 to 50 °F (4 to 10 °C)
for a minimum of 36 hours after
slaughter and that reached a pH of 5.8
or less in the loin muscle at the end of
the maturation period. It further states
that measurement of the pH must be
taken at the middle of both longissimus
dorsi muscles. Finally, it provides that
any carcass in which the pH does not
reach 5.8 or less may be allowed to
maturate an additional 24 hours and be
retested, and states that, if the carcass
still has not reached a pH of 5.8 or less
after 60 hours, the meat from the carcass
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may not be exported to the United
States. These requirements are based on
the fact that the FMD virus in meat is
inactivated by acidification, which
occurs naturally during maturation. An
acid environment of a pH of 5.8 or less
destroys the virus quickly. Accordingly,
we would subject ovine meat from
Uruguay to these same requirements.
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APHIS Inspection of Slaughtering
Establishments
Paragraph (j) of § 94.22 currently
requires that an authorized veterinary
official of the Government of Uruguay
certify on the foreign meat inspection
certificate that the conditions for
importation of the beef have been met.
Similarly, paragraph (k) currently
requires that the establishment in which
the bovines are slaughtered allow
periodic APHIS inspection of their
facilities, records, and operations. We
would subject ovine meat from Uruguay
to these requirements. We believe that,
in the great majority of cases,
certification by an authorized veterinary
official of Uruguay will be sufficient
verification that the ovine meat has met
the conditions for importation into the
United States. However, because of the
possibility of occasional differing
interpretations of the regulations, we
consider it advisable to have provisions
within the regulations enabling APHIS
representatives to have access to
slaughtering establishments for periodic
inspections.
Finally, we note that, in addition to
the above provisions, any ovine meat
imported from Uruguay would have to
meet the additional certification
requirements under § 94.11(c). That
paragraph prohibits the export-approved
slaughter establishment from receiving
FMD-susceptible animals or animal
products that originated, transported, or
commingled with animals or animal
products from regions that APHIS does
not consider as FMD-free.
Executive Order 12866 and Regulatory
Flexibility Act
This proposed rule has been
determined to be not significant for the
purposes of Executive Order 12866 and,
therefore, has not been reviewed by the
Office of Management and Budget.
We are proposing to amend the
regulations governing the importation of
certain animals, meat, and other animal
products by allowing, under certain
conditions, the importation of fresh
(chilled or frozen) ovine meat from
Uruguay. Based on the evidence in a
recent risk assessment, we believe that
fresh (chilled or frozen) ovine meat can
be safely imported from Uruguay
provided certain conditions are met.
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We have prepared an economic
analysis for this proposed rule. The
analysis, which considers the number of
and type of entities that are likely to be
affected by this action and the potential
economic effects on those entities,
provides the basis for the
Administrator’s determination that this
action would not have a significant
impact on a substantial number of small
entities. The economic analysis may be
viewed on the Regulations.gov Web site
(see ADDRESSES above for instructions
for accessing Regulations.gov). Copies of
the economic analysis are also available
from the person listed under FOR
FURTHER INFORMATION CONTACT.
Executive Order 12988
This proposed rule has been reviewed
under Executive Order 12988, Civil
Justice Reform. If this proposed rule is
adopted: (1) No retroactive effect will be
given to this rule and (2) administrative
proceedings will not be required before
parties may file suit in court challenging
this rule.
Paperwork Reduction Act
In accordance with section 3507(d) of
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.), the information
collection or recordkeeping
requirements included in this proposed
rule have been submitted for approval to
the Office of Management and Budget
(OMB). Please send written comments
to the Office of Information and
Regulatory Affairs, OMB, Attention:
Desk Officer for APHIS, Washington, DC
20503. Please state that your comments
refer to Docket No. APHIS–2008–0085.
Please send a copy of your comments to:
(1) Docket No. APHIS–2008–0085,
Regulatory Analysis and Development,
PPD, APHIS, Station 3A–03.8, 4700
River Road Unit 118, Riverdale, MD
20737–1238, and (2) Clearance Officer,
OCIO, USDA, room 404–W, 14th Street
and Independence Avenue, SW.,
Washington, DC 20250. A comment to
OMB is best assured of having its full
effect if OMB receives it within 30 days
of publication of this proposed rule.
We are proposing to amend the
regulations governing the importation of
certain animals, meat, and other animal
products to allow, under certain
conditions, the importation of fresh
(chilled or frozen) ovine meat from
Uruguay. This action would provide for
the importation of ovine meat from
Uruguay into the United States, while
continuing to protect the United States
against the introduction of foot-andmouth disease. Under the proposed
regulations, APHIS would collect
information, provided by an authorized
certifying official of the Government of
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Uruguay, certifying that specific
conditions for importation have been
met.
We are soliciting comments from the
public (as well as affected agencies)
concerning our proposed information
collection and recordkeeping
requirements. These comments will
help us:
(1) Evaluate whether the proposed
information collection is necessary for
the proper performance of our agency’s
functions, including whether the
information will have practical utility;
(2) Evaluate the accuracy of our
estimate of the burden of the proposed
information collection, including the
validity of the methodology and
assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and
(4) Minimize the burden of the
information collection on those who are
to respond (such as through the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology; e.g., permitting
electronic submission of responses).
Estimate of burden: Public reporting
burden for this collection of information
is estimated to average 1.6 hours per
response.
Respondents: Animal health officials
of the government of Uruguay.
Estimated annual number of
respondents: 5.
Estimated annual number of
responses per respondent: 1.
Estimated annual number of
responses: 5.
Estimated total annual burden on
respondents: 8 hours. (Due to averaging,
the total annual burden hours may not
equal the product of the annual number
of responses multiplied by the reporting
burden per response.)
Copies of this information collection
can be obtained from Mrs. Celeste
Sickles, APHIS’ Information Collection
Coordinator, at (301) 851–2908.
E-Government Act Compliance
The Animal and Plant Health
Inspection Service is committed to
compliance with the E-Government Act
to promote the use of the Internet and
other information technologies, to
provide increased opportunities for
citizen access to Government
information and services, and for other
purposes. For information pertinent to
E-Government Act compliance related
to this proposed rule, please contact
Mrs. Celeste Sickles, APHIS’
Information Collection Coordinator, at
(301) 851–2908.
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Federal Register / Vol. 76, No. 37 / Thursday, February 24, 2011 / Proposed Rules
National Environmental Policy Act
To provide the public with
documentation of APHIS’ review and
analysis of any potential environmental
impacts associated with allowing the
importation of ovine meat from Uruguay
into the United States, we have
prepared an environmental assessment.
The environmental assessment was
prepared in accordance with: (1) The
National Environmental Policy Act of
1969 (NEPA), as amended (42 U.S.C.
4321 et seq.), (2) regulations of the
Council on Environmental Quality for
implementing the procedural provisions
of NEPA (40 CFR parts 1500–1508), (3)
USDA regulations implementing NEPA
(7 CFR part 1b), and (4) APHIS’ NEPA
Implementing Procedures (7 CFR part
372).
The environmental assessment may
be viewed on the Internet on the
Regulations.gov Web site and is
available for public inspection in our
reading room. (Instructions for accessing
Regulations.gov and information on the
location and hours of the reading room
are provided under the heading
ADDRESSES at the beginning of this
proposed rule.) In addition, copies may
be obtained by calling or writing to the
individual listed under FOR FURTHER
INFORMATION CONTACT.
List of Subjects in 9 CFR Part 94
Animal diseases, Imports, Livestock,
Meat and meat products, Milk, Poultry
and poultry products, Reporting and
recordkeeping requirements.
Accordingly, we are proposing to
amend 9 CFR Part 94 as follows:
PART 94—RINDERPEST, FOOT-ANDMOUTH DISEASE, EXOTIC
NEWCASTLE DISEASE, AFRICAN
SWINE FEVER, CLASSICAL SWINE
FEVER, SWINE VESICULAR DISEASE,
AND BOVINE SPONGIFORM
ENCEPHALOPATHY: PROHIBITED
AND RESTRICTED IMPORTATIONS
1. The authority citation for part 94
continues to read as follows:
Authority: 7 U.S.C. 450, 7701–7772, and
8301–8317; 21 U.S.C. 136 and 136a; 31
U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.
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2. Section 94.1 is amended by revising
paragraph (b)(4) and the introductory
text of paragraph (d) to read as follows:
§ 94.1 Regions where rinderpest or footand-mouth disease exists; importations
prohibited.
*
*
*
*
*
(b) * * *
(4) Except as provided in § 94.22 for
fresh (chilled or frozen) beef and ovine
meat from Uruguay.
*
*
*
*
*
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(d) Except as otherwise provided in
this part, fresh (chilled or frozen) meat
of ruminants or swine raised and
slaughtered in a region free of foot-andmouth disease and rinderpest, as
designated in paragraph (a)(2) of this
section, and fresh (chilled or frozen)
beef and ovine meat exported from
Uruguay in accordance with § 94.22,
which during shipment to the United
States enters a port or otherwise transits
a region where rinderpest or foot-andmouth disease exists, may be imported
provided that all of the following
conditions are met:
*
*
*
*
*
3. Section 94.22 is revised to read as
follows:
§ 94.22 Restrictions on importation of beef
and ovine meat from Uruguay.
Notwithstanding any other provisions
of this part, fresh (chilled or frozen) beef
and ovine meat from Uruguay may be
exported to the United States under the
following conditions:
(a) The meat is beef and ovine meat
from animals that have been born,
raised, and slaughtered in Uruguay.
(b) If foot-and-mouth disease is
detected anywhere in Uruguay, the
export of beef and ovine meat from all
of Uruguay to the United States is
prohibited until at least 12 months have
elapsed since the depopulation,
cleaning, and disinfection of the last
infected premises.
(c) The meat comes from bovines and
sheep that originate from premises
where foot-and-mouth disease has not
been present during the lifetime of any
bovines and sheep slaughtered for the
export of beef and ovine meat to the
United States.
(d) The meat comes from bovines and
sheep that were moved directly from the
premises of origin to the slaughtering
establishment without any contact with
other animals.
(e) The meat comes from bovines and
sheep that received ante-mortem and
post-mortem veterinary inspections,
paying particular attention to the head
and feet, at the slaughtering
establishment, with no evidence found
of vesicular disease.
(f) The meat consists only of bovine
parts and ovine parts that are, by
standard practice, part of the animal’s
carcass that is placed in a chiller for
maturation after slaughter. The bovine
and ovine parts that may not be
imported include all parts of the head,
feet, hump, hooves, and internal organs.
(g) All bone and visually identifiable
blood clots and lymphoid tissue have
been removed from the meat.
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10269
(h) The meat has not been in contact
with meat from regions other than those
listed in § 94.1(a)(2).
(i) The meat comes from carcasses
that were allowed to maturate at 40 to
50 °F (4 to 10 °C) for a minimum of 36
hours after slaughter and that reached a
pH of 5.8 or less in the loin muscle at
the end of the maturation period.
Measurements for pH must be taken at
the middle of both longissimus dorsi
muscles. Any carcass in which the pH
does not reach 5.8 or less may be
allowed to maturate an additional 24
hours and be retested, and, if the carcass
still has not reached a pH of 5.8 or less
after 60 hours, the meat from the carcass
may not be exported to the United
States.
(j) An authorized veterinary official of
the Government of Uruguay certifies on
the foreign meat inspection certificate
that the above conditions have been
met.
(k) The establishment in which the
bovines and sheep are slaughtered
allows periodic on-site evaluation and
subsequent inspection of its facilities,
records, and operations by an APHIS
representative.
Done in Washington, DC, this 18th day of
February 2011.
Kevin Shea,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. 2011–4138 Filed 2–23–11; 8:45 am]
BILLING CODE 3410–34–P
NUCLEAR REGULATORY
COMMISSION
10 CFR Part 52
[NRC–2010–0131]
RIN 3150–AI81
AP1000 Design Certification
Amendment
Nuclear Regulatory
Commission.
ACTION: Proposed rule.
AGENCY:
The U.S. Nuclear Regulatory
Commission (NRC or Commission)
proposes to amend its regulations to
certify an amendment to the AP1000
standard plant design. The purpose of
the amendment is to replace the
combined license (COL) information
items and design acceptance criteria
(DAC) with specific design information,
address the effects of the impact of a
large commercial aircraft, incorporate
design improvements, and increase
standardization of the design. Upon
NRC rulemaking approval of its
amendment to the AP1000 design, an
SUMMARY:
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Agencies
[Federal Register Volume 76, Number 37 (Thursday, February 24, 2011)]
[Proposed Rules]
[Pages 10266-10269]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-4138]
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Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 76, No. 37 / Thursday, February 24, 2011 /
Proposed Rules
[[Page 10266]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Part 94
[Docket No. APHIS-2008-0085]
RIN 0579-AD17
Importation of Ovine Meat From Uruguay
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Proposed rule.
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SUMMARY: We are proposing to amend the regulations governing the
importation of certain animals, meat, and other animal products to
allow, under certain conditions, the importation of fresh (chilled or
frozen) ovine meat from Uruguay. Based on the evidence in a risk
assessment that we have prepared, we believe that fresh (chilled or
frozen) ovine meat can safely be imported from Uruguay provided certain
conditions are met. These actions would provide for the importation of
ovine meat from Uruguay into the United States, while continuing to
protect the United States against the introduction of foot-and-mouth
disease.
DATES: We will consider all comments that we receive on or before April
25, 2011.
ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to https://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2008-0085 to submit or view comments and
to view supporting and related materials available electronically.
Postal Mail/Commercial Delivery: Please send one copy of
your comment to Docket No. APHIS-2008-0085, Regulatory Analysis and
Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118,
Riverdale, MD 20737-1238. Please state that your comment refers to
Docket No. APHIS-2008-0085.
Reading Room: You may read any comments that we receive on this
docket in our reading room. The reading room is located in room 1141 of
the USDA South Building, 14th Street and Independence Avenue SW.,
Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m.,
Monday through Friday, except holidays. To be sure someone is there to
help you, please call (202) 690-2817 before coming.
Other Information: Additional information about APHIS and its
programs is available on the Internet at https://www.aphis.usda.gov.
FOR FURTHER INFORMATION CONTACT: Dr. Silvia Kreindel, Senior Staff
Veterinarian, Regionalization Evaluation Services Staff, VS, APHIS,
4700 River Road Unit 38, Riverdale, MD 20737-1231; (301) 734-8419.
SUPPLEMENTARY INFORMATION:
Background
Under the Animal Health Protection Act (7 U.S.C. 8301 et seq.), the
Secretary of Agriculture may prohibit the importation of any animal or
article if the Secretary determines that the prohibition is necessary
to prevent the introduction into or dissemination within the United
States of any pest or disease of livestock.
Pursuant to this Act, the Animal and Plant Health Inspection
Service (APHIS) of the United States Department of Agriculture (USDA)
regulates the importation of animals and animal products into the
United States to guard against the introduction of animal diseases not
currently present or prevalent in this country. The regulations in 9
CFR part 94 (referred to below as the regulations) prohibit or restrict
the importation of specified animals and animal products to prevent the
introduction into the United States of various animal diseases,
including rinderpest and foot-and-mouth disease (FMD). These are
dangerous and destructive communicable diseases of ruminants and swine.
Section 94.1 of the regulations lists regions of the world that are
declared free of rinderpest and FMD. Section 94.11 lists regions that
have been determined to be free of rinderpest and FMD, but that are
subject to certain restrictions because of their proximity to or
trading relationships with rinderpest- or FMD-affected regions.
In a final rule effective and published in the Federal Register on
May 29, 2003 (68 FR 31940-31949, Docket No. 02-109-3), we amended the
regulations to authorize the importation of fresh beef from Uruguay, a
region of the world that we do not recognize as free of FMD, under
certain conditions. Those conditions, found in Sec. 94.22 of the
regulations, require that the meat come from bovines that have been
born, raised, and slaughtered in Uruguay, that the bovines have not
been exposed to FMD on their premises of origin or through contact with
bovines from other premises, that the bovines are subject to
inspections and processing designed to detect FMD and remove
potentially affected body parts, that the beef is subject to a
maturation process designed to deactivate the FMD virus, that Uruguay
is free of FMD for a year prior to the export of the beef, and that the
beef has not come in contact with meat from FMD-affected regions.
In 2006, Uruguay's Ministry of Livestock, Agriculture, and
Fisheries (MGAP) submitted information to APHIS in support of their
request that we amend the regulations to allow the importation of fresh
ovine meat into the United States.
In response to this request, APHIS prepared a risk assessment,
which can be viewed on the Internet on the Regulations.gov Web site or
in our reading room.\1\ This assessment pays close attention, in
particular, to the role sheep played in the last outbreak of FMD in
Uruguay in 2001, and the likelihood that FMD has been introduced into
the domestic ovine population within the country since that time. In
addition, as part of our evaluation of the risks associated with
Uruguay's request, APHIS conducted a site visit in Uruguay in March
2007.
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\1\ Instructions on accessing Regulations.gov and information on
the location and hours of the reading room may be found at the
beginning of this document under ADDRESSES. You may also request
paper copies of the risk assessment by calling or writing the person
listed under FOR FURTHER INFORMATION CONTACT.
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Based on the risk assessment and the site visit, we have determined
that it is not necessary to prohibit the importation of fresh (chilled
or frozen) ovine meat from Uruguay, provided certain requirements,
similar to those described above for fresh beef and discussed later in
this document, are met. These requirements would be
[[Page 10267]]
nearly identical to the existing requirements for the importation of
beef; hence we are proposing to revise Sec. 94.22 to authorize the
importation of both beef and ovine meat from Uruguay into the United
States.
Mitigation Measures for the Importation of Ovine Meat From Uruguay
There are several risk factors associated with the importation of
ovine meat from Uruguay. We discuss our proposed mitigation measures
for these risk factors in the following paragraphs.
Uruguayan Origin of Ovine Meat; Restrictions on Contact With Meat of a
Different Region of Origin
Currently, paragraph (a) of Sec. 94.22 requires that beef from
Uruguay must come from bovines that have been born, raised, and
slaughtered in Uruguay. Likewise, paragraph (h) of Sec. 94.22
currently requires that beef from Uruguay not have been in contact with
meat from regions other than those listed in Sec. 94.1(a)(2), which
lists regions declared to be free of both rinderpest and FMD. We would
subject ovine meat from Uruguay to these same requirements. As
documented in our assessment, Brazil and Argentina, countries that
border Uruguay, both experienced outbreaks of FMD as recently as 2006,
and FMD is under control, but endemic, in the region of South America
surrounding Uruguay.
FMD Status of Uruguay
Currently, paragraph (b) of Sec. 94.22 requires that FMD not have
been diagnosed in Uruguay within the previous 12 months before beef
from Uruguay is exported to the United States. We would amend the
paragraph so that it would state that, if FMD is detected anywhere in
Uruguay, the export of beef and ovine meat from all of Uruguay to the
United States is prohibited until at least 12 months have elapsed since
the depopulation, cleaning, and disinfection of the last infected
premises. The current provision could be construed to state that the 12
month prohibition begins following diagnosis of the last affected
animal during an outbreak, while eradication, cleaning, and
disinfection efforts are still ongoing. This is not the case; it is
APHIS' policy that the 12 month prohibition begins only after all
``stamping out'' efforts cease.
Premises of Origin
Paragraph (c) of Sec. 94.22 currently requires that beef from
Uruguay exported to the United States come from bovines that originated
from premises where FMD has not been present during the lifetime of any
bovines slaughtered for the export of beef to the United States. We
would modify paragraph (c) so that it would pertain to both bovines and
sheep. This measure is necessary because sheep that have been exposed
to FMD on their premises of origin pose an unacceptably high risk of
spreading the disease.
Movement From the Premises of Origin
Paragraph (d) of Sec. 94.22 currently requires that beef from
Uruguay come from bovines that were moved directly from the premises of
origin to the slaughtering establishment without any contact with other
animals. We would also subject ovine meat from Uruguay to this
requirement, which addresses the risk of cattle or sheep coming into
contact with or commingling during transit to slaughter with animals
from regions in which FMD is known to exist, or that have not been
evaluated by APHIS with regard to their FMD status.
Ante- and Post-Mortem Inspections
Paragraph (e) of Sec. 94.22 currently requires that beef from
Uruguay come from bovines that received ante- and post-mortem
veterinary inspections, paying particular attention to the head and
feet, at the slaughtering establishment, with no evidence found of
vesicular disease. Because FMD has a short incubation period, if
animals were infected with FMD at a premises of origin, it is likely
that lesions would be visible in at least a few of those animals at the
slaughtering establishment prior to slaughter. Similarly, post-mortem
inspection of carcasses would be likely to identify any lesions and
vesicles in animals infected with FMD. Since the lesions associated
with FMD occur primarily on the feet and in the mouth, particular
attention must be paid to the head and feet during these inspections.
Because ante- and post-mortem inspections are effective in reducing
disease risk, we are proposing to also require ante- and post-mortem
inspections for sheep slaughtered for the export of fresh (chilled or
frozen) ovine meat from Uruguay to the United States.
Restrictions on Certain Ovine Parts
Paragraph (f) of Sec. 94.22 currently requires that beef from
Uruguay consist only of bovine parts that are, by standard practice,
part of the animal's carcass that is placed in a chiller for maturation
after slaughter. Accordingly, the paragraph prohibits the importation
of all parts of bovine heads, feet, hump, hooves, or internal organs.
We would apply this requirement to ovine meat from Uruguay, and
would therefore authorize the importation into the United States only
of ovine parts that are, by standard practice, part of the animal's
carcass that is placed in a chiller for maturation after slaughter. As
a result, we would continue to prohibit the importation of ovine heads,
feet, hooves, and internal organs into the United States; sheep have no
humps.
While portions of a sheep's head, feet, hooves, and internal organs
may reach the necessary pH level to inactivate the FMD virus during the
required maturation process (see the section below titled ``Maturation
Process''), these items can contain lymph tissue, depot fat, and blood
clots that may potentially harbor active FMD virus, even after that
process; hence the need for this requirement.
Bone, Blood Clots, and Lymphoid Tissue
Paragraph (g) of Sec. 94.22 currently requires all bone and
visually identifiable blood clots and lymphoid tissue to be removed
from beef from Uruguay prior to export to the United States. We would
subject ovine meat from Uruguay to this same requirement.
The removal of bones and visually identifiable blood clots is
necessary because any FMD virus these parts might potentially harbor
may not be inactivated by the maturation process described later in
this document. Although we consider the removal of these parts to be
necessary, we recognize that meat may contain small portions of blood
clots or lymphoid tissue that are not visually identifiable as such.
Because such small parts are unlikely to harbor any FMD virus that is
not inactivated by the maturation process, and because we recognize
that it would be difficult, if not impossible, to remove parts of blood
clots or lymphoid tissue that are not recognizable as such, we have
specified that all visually identifiable blood clots and lymphoid
tissue would have to be removed.
Maturation Process
Paragraph (i) of Sec. 94.22 currently requires that beef from
Uruguay come from bovine carcasses that were allowed to maturate at 40
to 50 [deg]F (4 to 10 [deg]C) for a minimum of 36 hours after slaughter
and that reached a pH of 5.8 or less in the loin muscle at the end of
the maturation period. It further states that measurement of the pH
must be taken at the middle of both longissimus dorsi muscles. Finally,
it provides that any carcass in which the pH does not reach 5.8 or less
may be allowed to maturate an additional 24 hours and be retested, and
states that, if the carcass still has not reached a pH of 5.8 or less
after 60 hours, the meat from the carcass
[[Page 10268]]
may not be exported to the United States. These requirements are based
on the fact that the FMD virus in meat is inactivated by acidification,
which occurs naturally during maturation. An acid environment of a pH
of 5.8 or less destroys the virus quickly. Accordingly, we would
subject ovine meat from Uruguay to these same requirements.
APHIS Inspection of Slaughtering Establishments
Paragraph (j) of Sec. 94.22 currently requires that an authorized
veterinary official of the Government of Uruguay certify on the foreign
meat inspection certificate that the conditions for importation of the
beef have been met. Similarly, paragraph (k) currently requires that
the establishment in which the bovines are slaughtered allow periodic
APHIS inspection of their facilities, records, and operations. We would
subject ovine meat from Uruguay to these requirements. We believe that,
in the great majority of cases, certification by an authorized
veterinary official of Uruguay will be sufficient verification that the
ovine meat has met the conditions for importation into the United
States. However, because of the possibility of occasional differing
interpretations of the regulations, we consider it advisable to have
provisions within the regulations enabling APHIS representatives to
have access to slaughtering establishments for periodic inspections.
Finally, we note that, in addition to the above provisions, any
ovine meat imported from Uruguay would have to meet the additional
certification requirements under Sec. 94.11(c). That paragraph
prohibits the export-approved slaughter establishment from receiving
FMD-susceptible animals or animal products that originated,
transported, or commingled with animals or animal products from regions
that APHIS does not consider as FMD-free.
Executive Order 12866 and Regulatory Flexibility Act
This proposed rule has been determined to be not significant for
the purposes of Executive Order 12866 and, therefore, has not been
reviewed by the Office of Management and Budget.
We are proposing to amend the regulations governing the importation
of certain animals, meat, and other animal products by allowing, under
certain conditions, the importation of fresh (chilled or frozen) ovine
meat from Uruguay. Based on the evidence in a recent risk assessment,
we believe that fresh (chilled or frozen) ovine meat can be safely
imported from Uruguay provided certain conditions are met.
We have prepared an economic analysis for this proposed rule. The
analysis, which considers the number of and type of entities that are
likely to be affected by this action and the potential economic effects
on those entities, provides the basis for the Administrator's
determination that this action would not have a significant impact on a
substantial number of small entities. The economic analysis may be
viewed on the Regulations.gov Web site (see ADDRESSES above for
instructions for accessing Regulations.gov). Copies of the economic
analysis are also available from the person listed under FOR FURTHER
INFORMATION CONTACT.
Executive Order 12988
This proposed rule has been reviewed under Executive Order 12988,
Civil Justice Reform. If this proposed rule is adopted: (1) No
retroactive effect will be given to this rule and (2) administrative
proceedings will not be required before parties may file suit in court
challenging this rule.
Paperwork Reduction Act
In accordance with section 3507(d) of the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the information collection or
recordkeeping requirements included in this proposed rule have been
submitted for approval to the Office of Management and Budget (OMB).
Please send written comments to the Office of Information and
Regulatory Affairs, OMB, Attention: Desk Officer for APHIS, Washington,
DC 20503. Please state that your comments refer to Docket No. APHIS-
2008-0085. Please send a copy of your comments to: (1) Docket No.
APHIS-2008-0085, Regulatory Analysis and Development, PPD, APHIS,
Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238,
and (2) Clearance Officer, OCIO, USDA, room 404-W, 14th Street and
Independence Avenue, SW., Washington, DC 20250. A comment to OMB is
best assured of having its full effect if OMB receives it within 30
days of publication of this proposed rule.
We are proposing to amend the regulations governing the importation
of certain animals, meat, and other animal products to allow, under
certain conditions, the importation of fresh (chilled or frozen) ovine
meat from Uruguay. This action would provide for the importation of
ovine meat from Uruguay into the United States, while continuing to
protect the United States against the introduction of foot-and-mouth
disease. Under the proposed regulations, APHIS would collect
information, provided by an authorized certifying official of the
Government of Uruguay, certifying that specific conditions for
importation have been met.
We are soliciting comments from the public (as well as affected
agencies) concerning our proposed information collection and
recordkeeping requirements. These comments will help us:
(1) Evaluate whether the proposed information collection is
necessary for the proper performance of our agency's functions,
including whether the information will have practical utility;
(2) Evaluate the accuracy of our estimate of the burden of the
proposed information collection, including the validity of the
methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to
be collected; and
(4) Minimize the burden of the information collection on those who
are to respond (such as through the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology; e.g., permitting electronic
submission of responses).
Estimate of burden: Public reporting burden for this collection of
information is estimated to average 1.6 hours per response.
Respondents: Animal health officials of the government of Uruguay.
Estimated annual number of respondents: 5.
Estimated annual number of responses per respondent: 1.
Estimated annual number of responses: 5.
Estimated total annual burden on respondents: 8 hours. (Due to
averaging, the total annual burden hours may not equal the product of
the annual number of responses multiplied by the reporting burden per
response.)
Copies of this information collection can be obtained from Mrs.
Celeste Sickles, APHIS' Information Collection Coordinator, at (301)
851-2908.
E-Government Act Compliance
The Animal and Plant Health Inspection Service is committed to
compliance with the E-Government Act to promote the use of the Internet
and other information technologies, to provide increased opportunities
for citizen access to Government information and services, and for
other purposes. For information pertinent to E-Government Act
compliance related to this proposed rule, please contact Mrs. Celeste
Sickles, APHIS' Information Collection Coordinator, at (301) 851-2908.
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National Environmental Policy Act
To provide the public with documentation of APHIS' review and
analysis of any potential environmental impacts associated with
allowing the importation of ovine meat from Uruguay into the United
States, we have prepared an environmental assessment. The environmental
assessment was prepared in accordance with: (1) The National
Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et
seq.), (2) regulations of the Council on Environmental Quality for
implementing the procedural provisions of NEPA (40 CFR parts 1500-
1508), (3) USDA regulations implementing NEPA (7 CFR part 1b), and (4)
APHIS' NEPA Implementing Procedures (7 CFR part 372).
The environmental assessment may be viewed on the Internet on the
Regulations.gov Web site and is available for public inspection in our
reading room. (Instructions for accessing Regulations.gov and
information on the location and hours of the reading room are provided
under the heading ADDRESSES at the beginning of this proposed rule.) In
addition, copies may be obtained by calling or writing to the
individual listed under FOR FURTHER INFORMATION CONTACT.
List of Subjects in 9 CFR Part 94
Animal diseases, Imports, Livestock, Meat and meat products, Milk,
Poultry and poultry products, Reporting and recordkeeping requirements.
Accordingly, we are proposing to amend 9 CFR Part 94 as follows:
PART 94--RINDERPEST, FOOT-AND-MOUTH DISEASE, EXOTIC NEWCASTLE
DISEASE, AFRICAN SWINE FEVER, CLASSICAL SWINE FEVER, SWINE
VESICULAR DISEASE, AND BOVINE SPONGIFORM ENCEPHALOPATHY: PROHIBITED
AND RESTRICTED IMPORTATIONS
1. The authority citation for part 94 continues to read as follows:
Authority: 7 U.S.C. 450, 7701-7772, and 8301-8317; 21 U.S.C.
136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.
2. Section 94.1 is amended by revising paragraph (b)(4) and the
introductory text of paragraph (d) to read as follows:
Sec. 94.1 Regions where rinderpest or foot-and-mouth disease exists;
importations prohibited.
* * * * *
(b) * * *
(4) Except as provided in Sec. 94.22 for fresh (chilled or frozen)
beef and ovine meat from Uruguay.
* * * * *
(d) Except as otherwise provided in this part, fresh (chilled or
frozen) meat of ruminants or swine raised and slaughtered in a region
free of foot-and-mouth disease and rinderpest, as designated in
paragraph (a)(2) of this section, and fresh (chilled or frozen) beef
and ovine meat exported from Uruguay in accordance with Sec. 94.22,
which during shipment to the United States enters a port or otherwise
transits a region where rinderpest or foot-and-mouth disease exists,
may be imported provided that all of the following conditions are met:
* * * * *
3. Section 94.22 is revised to read as follows:
Sec. 94.22 Restrictions on importation of beef and ovine meat from
Uruguay.
Notwithstanding any other provisions of this part, fresh (chilled
or frozen) beef and ovine meat from Uruguay may be exported to the
United States under the following conditions:
(a) The meat is beef and ovine meat from animals that have been
born, raised, and slaughtered in Uruguay.
(b) If foot-and-mouth disease is detected anywhere in Uruguay, the
export of beef and ovine meat from all of Uruguay to the United States
is prohibited until at least 12 months have elapsed since the
depopulation, cleaning, and disinfection of the last infected premises.
(c) The meat comes from bovines and sheep that originate from
premises where foot-and-mouth disease has not been present during the
lifetime of any bovines and sheep slaughtered for the export of beef
and ovine meat to the United States.
(d) The meat comes from bovines and sheep that were moved directly
from the premises of origin to the slaughtering establishment without
any contact with other animals.
(e) The meat comes from bovines and sheep that received ante-mortem
and post-mortem veterinary inspections, paying particular attention to
the head and feet, at the slaughtering establishment, with no evidence
found of vesicular disease.
(f) The meat consists only of bovine parts and ovine parts that
are, by standard practice, part of the animal's carcass that is placed
in a chiller for maturation after slaughter. The bovine and ovine parts
that may not be imported include all parts of the head, feet, hump,
hooves, and internal organs.
(g) All bone and visually identifiable blood clots and lymphoid
tissue have been removed from the meat.
(h) The meat has not been in contact with meat from regions other
than those listed in Sec. 94.1(a)(2).
(i) The meat comes from carcasses that were allowed to maturate at
40 to 50 [deg]F (4 to 10 [deg]C) for a minimum of 36 hours after
slaughter and that reached a pH of 5.8 or less in the loin muscle at
the end of the maturation period. Measurements for pH must be taken at
the middle of both longissimus dorsi muscles. Any carcass in which the
pH does not reach 5.8 or less may be allowed to maturate an additional
24 hours and be retested, and, if the carcass still has not reached a
pH of 5.8 or less after 60 hours, the meat from the carcass may not be
exported to the United States.
(j) An authorized veterinary official of the Government of Uruguay
certifies on the foreign meat inspection certificate that the above
conditions have been met.
(k) The establishment in which the bovines and sheep are
slaughtered allows periodic on-site evaluation and subsequent
inspection of its facilities, records, and operations by an APHIS
representative.
Done in Washington, DC, this 18th day of February 2011.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2011-4138 Filed 2-23-11; 8:45 am]
BILLING CODE 3410-34-P